CART-19 Cells For R/R B-ALL

Relapsed/Refractory B-cell ALL Clinical Trial

— CCFRRBA  

Official title:

CART-19 Cells For Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03391739
• Other study ID #: CART-19-03
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: December 30, 2017
• Last updated: December 30, 2017
• Start date: January 2016
• Est. completion date: December 2019

Study information

• Verified date: December 2017
• Source: Fujian Medical University
• Contact: Jianda Hu, Prof.M.D.Ph.D
• Phone: 86-13959169016
• Email: drjiandahu[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

There are limited treatment options for relapse/refractory B-cell acute lymphoblastic leukemia(ALL). However,CART-19 cells has emerged as a powerful targeted immunotherapy for highly refractory CD19+ acute lymphoblastic leukemia (ALL). This study aims to assess the safety and toxicity of CART-19 cells to patients with relapse/refractory B-cell ALL.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 60 Years

Eligibility

Inclusion Criteria:

• Signed written informed consent

• Aged between 1-60 years

• Patients with relapsed/refractory B-cell ALL

• Cardiac: Left ventricular ejection fraction = 50%

• Adequate renal and hepatic function

• Performance status: Karnofsky = 70%

Exclusion Criteria:

• Pregnant or lactating females.

• Any co-morbidity precluding the administration of CART-19 cells.

Related Conditions & MeSH terms

• Relapsed/Refractory B-cell ALL

Intervention

Biological:
• CART-19 cells
CART-19 cells treat

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Leukemia free survival		1 year
Secondary	Adverse events that are related to treatment		1 year